Alemtuzumab and CHOP Chemotherapy for Aggressive Histological Peripheral T-Cell Lymphomas

NCT00453427 | Completed Phase 1 DMC

• 1 other identifier: CTA-Control-103662
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objectives of this study are to:

1. 1.establish the safety and dose limiting toxicities of combining alemtuzumab with CHOP chemotherapy for patients with newly diagnosed aggressive T-cell lymphomas; and
2. 2.to measure the pharmacokinetics of alemtuzumab used in different subcutaneous doses and schedules.
3. 3.establish the efficacy of combination alemtuzumab with CHOP chemotherapy; and
4. 4.to measure the effects of combination alemtuzumab with CHOP chemotherapy on T-cell reconstitution and cytomegalovirus (CMV) reactivation.

Conditions

Peripheral T-cell Lymphomas

Keywords

PTL NOS; AILD; NHL; CHOP

Outcome Measures

Primary Outcomes (1)

• toxicity

  8 cycles of treatment

Secondary Outcomes (4)

• efficacy

  Post cycle 3 and Post cycle 8

• tumour response

  Post Cycle 3 and Post Cycle 8 Q 6 months in Followup

• pharmacokinetic analysis

  Day 1 of 8 Cycles of treatment and Post Last Dose on Day 3,6,10,13

• immunological monitoring

  Baseline Day 1 On Treatment Day 1 Cycle 4 and Cycle 8 and 6 months Follow-up

Interventions

Alemtuzumab (Campath-1H) DRUG

The investigational drug is alemtuzumab (Campath-1H). It is a recombinant humanized monoclonal antibody directed against the CD52 antigen on most (\> 95%) normal lymphocytes and T-cell and B-cell lymphomas. Alemtuzumab binds to the CD52 antigen on the cell surface, activating antibody-dependent cellular cytotoxicity, complement binding, apoptosis, cellular opsonization, and anti-tumour T-cell activity.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years of age or older at time of enrollment,
• Histologically proven and centrally reviewed CD52+ T-cell NHL Stages 2-4 including the following nodal and extranodal subtypes:
• Nodal:
• Peripheral T-cell lymphoma not otherwise specified (PTL NOS)
• Angioimmunoblastic lymphadenopathy (AILD)
• ALK 1 negative anaplastic large cell NHL
• Extranodal:
• Hepatosplenic
• Enteropathy-associated
• Panniculitic

You may not qualify if:

• Previous treatment with chemotherapy or radiation with the exception of up to 1 cycle of CHOP chemotherapy.
• Expected survival \< 4 months.
• ECOG performance status \> 3.
• Inadequate haematologic function (Hb \< 85g/L, ANC \< 1000/mm3, or platelet count \< 75,000/mm3) unless directly attributable to the NHL.
• Inadequate hepatic function (total bilirubin \> 35μmol/L, alkaline phosphatase \> 2x UL normal, AST/ALT \> 2x UL normal)
• Inadequate renal function (serum creatinine \> 130μmol/L), unless directly attributable to the NHL.
• Non-measurable or non-evaluable disease, according to criteria of Cheson et al49.
• Geographically inaccessible for follow-up
• Known hypersensitivity to study drugs
• Serious illnesses that may interfere with subject compliance, determination of causality of adverse events or would compromise other protocol objectives.
• Known HIV positivity or other pre-existing immunodeficiency (e.g., post-organ transplant).
• Known CNS involvement with lymphoma (tests to investigate CNS involvement are required only if clinically indicated).
• Pregnant or lactating women.
• Women who are of childbearing potential but are not using effective contraception. Men with reproductive potential who are not using effective contraception.
• Previous malignancy within the last 5 years with the exception of cervical carcinoma in situ or non melanoma skin cancer.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Sunnybrook Health Sciences Centre: collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (5)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Rena Buckstein, MD

  Sunnybrook Health Sciences Centre, Odette Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2007
• First Posted: March 29, 2007
• Study Start: September 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: May 1, 2015
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

CA (5)